RadiForce RX570; RadiForce RX570-AR
EIZO CorporationThe RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.
Intended Use
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Technology
Color LCD monitor using IPS panel technology with 5 megapixel resolution (2048x2560), factory calibrated display modes including DICOM GSDF compliance, and variations with anti-glare or anti-reflection surface treatments. Comes with RadiCS software for quality control based on QC standards, allowing quantitative and visual tests to maintain monitor performance.
Performance
Bench testing following FDA guidelines for diagnostic radiology displays included measurements of spatial resolution, pixel defects, artifacts, temporal response, luminance, DICOM GSDF conformance, angular luminance dependency, luminance and chromaticity uniformity, luminance stability, noise, display reflections, contrast ratio, and color/gray tracking. The device showed equivalent performance to predicate devices with results meeting predefined criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/7/2024
1 month - 2
FDA Approval
11/27/2024
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